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FDA 510(k)

SIGMS PROCED. 228 UV LACTATE DEHYDRO

K-Number: K841917 · 1984-06-14

ApplicantSigma Diagnostics, Inc.
Decision Date1984-06-14
Product CodeCFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SIGMS PROCED. 228 UV LACTATE DEHYDRO is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Diagnostics, Inc.. It received FDA 510(k) clearance on 1984-06-14 under 510(k) number K841917. The device is classified under product code CFJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGMS PROCED. 228 UV LACTATE DEHYDRO?

SIGMS PROCED. 228 UV LACTATE DEHYDRO is a medical device that received FDA 510(k) clearance on 1984-06-14. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K841917.

When did SIGMS PROCED. 228 UV LACTATE DEHYDRO receive FDA 510(k) clearance?

SIGMS PROCED. 228 UV LACTATE DEHYDRO received FDA 510(k) clearance on 1984-06-14, under 510(k) number K841917.

Who is the listed applicant for SIGMS PROCED. 228 UV LACTATE DEHYDRO?

The FDA 510(k) record lists Sigma Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIGMS PROCED. 228 UV LACTATE DEHYDRO?

The FDA product code for SIGMS PROCED. 228 UV LACTATE DEHYDRO is CFJ.

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Other records listing Sigma Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K021162AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHEDK020109SIGMA DIAGNOSTICS ACCUCLOT LA CONTROLK013549SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971K013544SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096K013545SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221K012410INFINITY HBA KIT, MODELS 537-A, 537-B

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Related Devices (Code: CFJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K131975ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K091544S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017Alfa Wassermann, Inc.K051108PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEMAbaxis, Inc.K974859LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30Diagnostic Chemicals , Ltd.K973589LIQUID LDH-L REAGENT SETPointe Scientific, Inc.,K970684LACTATE DEHYDROGENASE (LD)Randox Laboratories, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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